Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative

Abstract

Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Broad consensus among sponsors, research staff, study participants, and advocates indicate that the current process could be improved to enhance participants' understanding of study-related information and meet the needs of individuals. The Clinical Trials Transformation Initiative (CTTI) convened a project to identify problems in the current process and to formulate recommendations for improvement. A literature review, expert interviews, and multi-stakeholder meeting were conducted to identify barriers and develop solutions for a more effective informed consent process. Four key topics were the foundation of the recommendations: 1) defining an effective informed consent process, 2) training research staff, 3) improving the informed consent document, and 4) exploring the use of electronic consent. The ideal informed consent process involves an ongoing, interactive conversation between the participant and knowledgeable, responsive research staff who were trained in best practices. The informed consent process should be supported by a tiered informed consent document that provides critically relevant information to aid in the decision to participate in a study. Adoption of the CTTI informed consent recommendations should lead to a more participant-centric informed consent process. Participant involvement better meets the needs of participants and benefits the clinical trial enterprise by promoting a research culture that encourages informed participation in clinical studies.

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“…We obtained approval from the participating institutional review boards, including approval for a waiver of written consent (Lentz, Kennett, Perlmutter, & Forrest, ). The first page of the survey listed the study information sheet, containing information about the study team, purpose and activities, as well as risk and benefits of participating.…”

Revised Common Rule Changes to the Consent Process and Consent Form

“…6 The summary should include a statement that the subject's participation is voluntary, an explanation of the purpose of the research, and a description of the procedures, as well as how long the subject will be involved in the study, the risks, the benefits, and the alternatives if the subject decides not to participate. 6,8,[9][10][11][15][16][17][18][19][20] The key information summary addresses a problem in the consent process. Research has documented that consent forms have become lengthy and complex, and many subjects therefore have limited understanding of the research for which they are providing consent.…”

“…The consent form should not only facilitate discussions that expand the subject's understanding of the study, but it also serves as a reference for the potential subject to take home as he/she considers whether to enroll in the study. [3][4][5][6][7][8] The Federal Policy for the Protection of Human Subjects, known as the Common Rule, is a set of regulations that guide the ethical conduct of human subjects research. Revisions to the Common Rule were published on January 19, 2017 with a general compliance date of January 19, 2019, the first significant changes to the rule since it was published in 1991.…”

Making Clinical Trials More Patient-Centered Using Digital Interactive E-Consent Tools

“…[15][16][17] Lentz and colleagues report professional consensus that the current informed consent process for clinical trials needs to improve to enhance participants' understanding. 18 One important improvement is greater retention of participants. To address the deficits, the Clinical Trials Transformation Initiative published recommendations to improve trial consent by including a tiered consent process that provides critically relevant information customized for decision making about trial participation.…”

“…To address the deficits, the Clinical Trials Transformation Initiative published recommendations to improve trial consent by including a tiered consent process that provides critically relevant information customized for decision making about trial participation. 18 Consistent with the initiative's efforts, the Department of Health and Human Services, in recognizing the need to improve the consent process for clinical studies, updated the Common Rule to include a requirement for a clear, concise, and focused summary of key information. 1 Drs.…”